Cetirizine Hydrochloride Tablets USP 10 mg — Class III drug recall D-0033-2026
Ongoing recall by JB Chemicals and Pharmaceuticals Ltd, reported 2025-10-29, distributed nationwide. Tablet/Capsules Imprinted with Wrong ID
| Recall number | D-0033-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | JB Chemicals and Pharmaceuticals Ltd, Mumbai, India |
| Recall initiated | 2025-09-12 |
| Classified | 2025-10-17 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 13,440 bottles |
| NDC | 16571-0402, 16571-0402-10, 16571-0402-30, 16571-0402-50 |
| Lot numbers | PY925013, PY925014 |
| Expiration dates | 2028-01-31 |
Product
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Reason for recall
Tablet/Capsules Imprinted with Wrong ID
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0033-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.